Prostate CancerNCT01508390
Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate
A study testing CyberKnife Boost in people with Prostate Cancer, run by Boston Medical Center at 1 site in United States.
Trial summary
In this study, participants will have standard Androgen Deprivation Therapy and undergo standard external beam radiation therapy to the prostate and at-risk lymph nodes by Intensity Modulated Radiation Therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- CyberKnife Boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven adenocarcinoma of the prostate
- Gleason score (2-10)
- Biopsy within six months of date of registration
- Patient age >18 years
- Clinical stage (American Joint Committee on Cancer 7th Edition)
- T-stage determined by physical exam (Digital Rectal Exam Required)
Show all 26Show fewer
- MRI findings (e.g. extracapsular extension) can be used to determine T-staging
- N-stage determined using abdominopelvic CT scan and/or MRI
- M-stage determined by physical exam, CT and/or MRI, and bone scan (must be M0, excepting Lymph nodes)
- Please note: a SPECT bone scan including a CT of the abdomen and pelvis or an F18 Fluciclovine PET/CT fulfills protocol criteria for both the abdominopelvic CT and bone scan.
- Patients must belong to one of the following risk groups:
- PSA > 20 and < 150 and/or
- Gleason 8-10 and/or
- > clinical T3a and/or
- Clinical N1
- OR
- PSA 10 - 20 AND
- Gleason 7 AND
- Clinical T2b - T2c
- Patient is receiving, or planning to receive standard androgen deprivation therapy and initial IMRT to the prostate and positive or at-risk lymph nodes.
- Prostate volume greater than 20 cc and less than 100 cc
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Patient has agreed to complete questionnaires
- Signed IRB approved informed consent
- Patient eligible to have an MRI
- Must be able to tolerate the confinement of an MRI procedure
Who cannot join
- No prior prostate surgery (including TURP) or prostate cancer treatment with the exception of androgen deprivation therapy
- No prior radiotherapy to the pelvis
- No implanted hardware (including metal) or other material that would prohibit appropriate treatment planning or treatment delivery
- No metastatic disease, with the exception of lymph node positive disease
- No chemotherapy for a malignancy in the last 5 years.
- No history of an invasive malignancy (other than basal or squamous skin cancers) in the last 5 years.
Show all 9Show fewer
- No heart pacemaker, No metallic foreign body (metal sliver) in the eye, No aneurysm clip in the brain
- No history of a pelvic or horseshoe kidney
- No diagnosis of inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate for Treatment of Localized, Non-Metastatic, High Risk Prostate Cancer
In this study, participants will have standard Androgen Deprivation Therapy and undergo standard external beam radiation therapy to the prostate and at-risk lymph nodes by Intensity Modulated Radiation Therapy. The subsequent *boost* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.
Read the detailed description
In this study, participants will have standard androgen deprivation therapy and undergo standard radiation therapy to the prostate and at-risk lymph nodes by intensity-modulated radiation therapy (IMRT). The subsequent *boost* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.
- Conditions
- Prostate Cancer
- Being tested
- CyberKnife Boost
- Keywords
- prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyberKnife BoostRadiation
Also called stereotactic radiotherapy, cyberknife, radiation
21 Gy in 7 Gy per day, 3 fractions, Every other day
| Study group | Role | What they receive |
|---|---|---|
| Boost | Experimental | CyberKnife Boost 21 Gy in 7 Gy per day, 3 fractions, Every other day Receives: Radiation: CyberKnife Boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Document rate of biochemical Disease-Free Survival (bDFS)
To document the rate of biochemical Disease-Free Survival (bDFS), American Society for Radiation Oncology definitions
Measured: 5 years
Secondary outcomes (6)
Rate of local failure
Rate of local failure
Measured: 5 years
Rate of distant failure
Rate of distant failure
Measured: 5 years
disease-free survival
disease-free survival
Measured: 5 years
Rate of disease-specific survival
Rate of disease-specific survival
Measured: 5 years
Rate of overall survival
Rate of overall survival
Measured: 5 years
Estimate the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity
rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity following combination androgen deprivation therapy, External Beam Radiation Therapy and CyberKnife radiosurgery as a boost
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startJun 2011
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ariel Hirsch, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508390
- Sponsor's protocol ID
- H-29665
- Status last verified
- Jul 2026
- First submitted
- 9 Dec 2011
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate for Treatment of Localized, Non-Metastatic, High Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT01508390
- Acronym / sponsor ID
- H-29665
- Conditions
- Prostate Cancer
- Keywords
- prostate
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, participants will have standard Androgen Deprivation Therapy and undergo standard external beam radiation therapy to the prostate and at-risk lymph nodes by Intensity Modulated Radiation Therapy. The subsequent *boost* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.
Detailed description
In this study, participants will have standard androgen deprivation therapy and undergo standard radiation therapy to the prostate and at-risk lymph nodes by intensity-modulated radiation therapy (IMRT). The subsequent *boost* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Boost | Experimental | Radiation: CyberKnife BoostCyberKnife Boost 21 Gy in 7 Gy per day, 3 fractions, Every other day |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Histologically proven adenocarcinoma of the prostate
- Clinical stage (American Joint Committee on Cancer 7th Edition)
- Please note: a SPECT bone scan including a CT of the abdomen and pelvis or an F18 Fluciclovine PET/CT fulfills protocol criteria for both the abdominopelvic CT and bone scan.
- Patients must belong to one of the following risk groups:
- OR
Key exclusion criteria (9 listed)
- No prior prostate surgery (including TURP) or prostate cancer treatment with the exception of androgen deprivation therapy
- No prior radiotherapy to the pelvis
- No implanted hardware (including metal) or other material that would prohibit appropriate treatment planning or treatment delivery
- No metastatic disease, with the exception of lymph node positive disease
- No chemotherapy for a malignancy in the last 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyberKnife BoostAlso: stereotactic radiotherapy, cyberknife, radiation21 Gy in 7 Gy per day, 3 fractions, Every other day | Radiation | Boost |
Primary outcome
Document rate of biochemical Disease-Free Survival (bDFS)
Time frame: 5 years
To document the rate of biochemical Disease-Free Survival (bDFS), American Society for Radiation Oncology definitions
6 secondary outcomes
Rate of local failure
Time frame: 5 years
Rate of distant failure
Time frame: 5 years
disease-free survival
Time frame: 5 years
Rate of disease-specific survival
Time frame: 5 years
Rate of overall survival
Time frame: 5 years
Estimate the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariel Hirsch, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CyberKnife Boost in people with Prostate Cancer, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Document rate of biochemical Disease-Free Survival (bDFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.